Dramatic and unprecedented changes are unfolding in the medical device industry thanks to the intense scrutiny being placed on the Food and Drug Administration’s 510k process to clear certain medical devices for sale in the U.S. marketplace.

I t all comes, of course, in response to President Obama’s efforts to minimize public risk and with the spotlight now firmly on the FDA’s approval process, medical device manufacturers are already scrambling as they prepare to navigate through more rigid requirements without delaying their time to market.

The 510k process is often called a “fast-track” program because it relies on previous approval of similar or so-called “predicate” devices in order to provide on average 30- to 90-day reviews of new products. Critics argue that the process has major problems in that it clears some products that should in fact be subjected to a more detailed process.

The reality is that the 510K clearance process is about to become much more rigorous and will in most cases translate into significantly more time and money being spent by manufacturers and OEMs to keep up. Changes could indeed have an impact on the entire business model. If companies begin facing new demands for additional information – including clinical studies and details not required in the past – their business model based on quick clearance and speedy time to market may become obsolete. The grim reality is that products recently submitted for 510k clearance could now face intense scrutiny and requests for additional information. Imagine the impact this could have on time-tomarket plans.

Organizations are looking at what they can do now before this becomes a monstrous issue for them. Not having the right response to changes will cause delays and for many companies right now, the risk of chaos is real and alarming.

Make no mistake – the risks associated with inaction cannot be overestimated. If you are not quick enough to respond to the changes that loom, the competition is going to beat you to the punch and get to market first. As we all know, being first to market with a quality product in the medical device sector is imperative because market share, once lost, will be difficult and expensive to regain. Speed combined with intelligent strategy and flawless execution will win the day.

As they stand at the precipice of change, smart companies are already seeking new ways to innovate and to respond to the quickly evolving competitive landscape. Many have begun engaging new strategic partners to collaborate in the innovation process. Public demand for quality products, combined with growing cost pressures, are prompting companies to turn back to their core efficiencies while relying on solid partnerships that alleviate serious cost woes.

Aside from changing the business model to innovate and improve product portfolios, companies are also seeking ways to mitigate risk. Longer term, the question of how the introduction of new products will continue to change must also be addressed.

The goal for some firms then is to replace a fully integrated business model with a more nimble, modular structure that gives an organization tremendous new time and cost efficiencies via outsourcing of design and development, manufacturing, regulatory processes, quality processes, and even supply management and distribution.

Instead of managing the entire product lifecycle in-house with a traditional silo approach, there is now a crucial need for organizations to focus on their core competencies and exploit synergies across all areas. A new nimble business model will require the right partnership to provide crucial help in aligning goals for more efficient planning and execution that eliminates redundant costs, mitigates risk, and minimizes exposures.

For example, medical device manufacturers traditionally rely on multiple partners to fulfill part of the manufacturing process. Managing multiple partners can become not only onerous, but impractical when trying to meet heightened FDA inquiry. Instead OEMs can consider selecting a strategic partner with the reach and depth to offer a reliable and extensive supply chain to meet the various immediate and emerging requirements. The right partner can provide that service through suppliers that it already has approved through its own design and development efforts, while including globally recognized standards such as ISO certifications.

Our customers are telling us that their strategic partners help ensure the best prospects for continued success in our changing industry. The right partner delivers a conceptual understanding of regulatory, design and development, manufacturing and compliance needs, and environments. It then combines those capabilities with speedy execution to create new levels of competitive advantage. Beyond that, organizations also should be looking for partners possessing exceptionally clear focus on trends in design, compliance, and manufacturing.

A robust quality and regulatory system is one example that can illustrate the value of an insightful and knowledgeable partner. Properly selected, a partner’s quality and regulatory systems can allow your company to more easily and profitably achieve essential business outcomes, while ensuring maximum effectiveness to achieve compliance with FDA requirements and expectations.

With proper knowledge, focus, and follow-through, these solutions can make an otherwise complex set of compliance functions and activities manageable and can position your organization for success by providing substantially improved compliance outcomes at greatly reduced costs. The ability to scale or adapt compliance-affected business operations today— without increasing fixed costs— is extremely important. A comprehensive review of information and effective regulatory trend analysis can be a critical element for FDA marketing approval.

Having the market intelligence to know where targets should be, and being able to anticipate, assess, and rapidly overcome any hurdles that arise, will provide advantages that separate the winners from the losers in the marketplace. And we only need to look at what is happening in the market today for convincing evidence of that.